Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer.

Abstract

BACKGROUND:

Irinotecan hydrochloride, a topoisomerase I inhibitor, is effective against small-cell lung cancer. In a phase 2 study of irinotecan plus cisplatin in patients with extensive small-cell lung cancer, there was a high response rate and a promising median survival time.

METHODS:

We conducted a multicenter, randomized, phase 3 study in which we compared irinotecan plus cisplatin with etoposide plus cisplatin in patients with extensive (metastatic) small-cell lung cancer.

RESULTS:

The planned size of the study population was 230 patients, but enrollment was terminated early because an interim analysis found a statistically significant difference in survival between the patients assigned to receive irinotecan and cisplatin and those assigned to receive etoposide and cisplatin; as a result, only 154 patients were enrolled. The median survival was 12.8 months in the irinotecan-plus-cisplatin group and 9.4 months in the etoposide-plus-cisplatin group (P=0.002 by the unadjusted log-rank test). At two years, the proportion of patients surviving was 19.5 percent in the irinotecan-plus-cisplatin group and 5.2 percent in the etoposide-plus-cisplatin group. Severe or life-threatening myelosuppression was more frequent in the etoposide-plus-cisplatin group than in the irinotecan-plus-cisplatin group, and severe or life-threatening diarrhea was more frequent in the irinotecan-plus-cisplatin group than in the etoposide-plus-cisplatin group.

CONCLUSIONS:

Irinotecan plus cisplatin is an effective treatment for metastatic small-cell lung cancer.

• Authors: Kazumasa Noda, Yutaka Nishiwaki, Masaaki Kawahara, Shunichi Negoro, Takahiko Sugiura, Akira Yokoyama, Masahiro Fukuoka, Kiyoshi Mori, Koshiro Watanabe, Tomohide Tamura, Seiichiro Yamamoto, Nagahiro Saijo, Japan Clinical Oncology Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 346 Issue 2 Pg. 85-91 (Jan 10 2002) ISSN: 1533-4406 [Electronic] United States
• PMID: 11784874 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Etoposide
• Irinotecan
• Cisplatin
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Carcinoma, Small Cell (drug therapy, mortality)
• Cisplatin (administration & dosage, adverse effects)
• Disease-Free Survival
• Etoposide (administration & dosage, adverse effects)
• Female
• Humans
• Irinotecan
• Lung Neoplasms (drug therapy, mortality)
• Male
• Middle Aged
• Survival Analysis